Barts & The London NHS Trust
London, UK, EC1A 7BE, United Kingdom
NCT Number: NCT01411371
Heart failure and atrial fibrillation (AF) often coexist, and each increases the morbidity and mortality associated with the other. The investigators hypothesized that restoration of normal sinus rhythm by catheter ablation is superior to medical treatment of AF in heart failure. This study randomizes patients with heart failure and persistent AF to medical treatment of AF or catheter ablation to restore sinus rhythm.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
London, UK, EC1A 7BE, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Catheter ablation of AF as described previously by our group (e.g. Hunter et al, Heart 2010).
Medical treatment of persistent AF as 'normal care'. Patients are randomised to medical treatment alone for atrial fibrillation. Treatment will be as per current guidelines for persistent atrial fibrillation, with rate control as first line (using beta-blockers, calcium channel blockers and digoxin as indicated) and rhythm control as second line (using sotalol, dronedarone, or amiodarone as indicated). (Both groups will receive standard heart failure medication including angiotensin converting enzyme inhibitors, beta blockers, aldosterone antagonists, and diuretics as indicated).
Time frame: 6 months
Difference in left ventricular ejection fraction between groups on echocardiography at 6 months
Time frame: 6 months
Looking at peak volume oxygen updake between groups
Time frame: 6 months
NYHA Functional Classification. classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain (Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
No NYHA class listed or unable to determine.)
Time frame: 6 months
Difference in BNP between groups from 1 month onwards
Time frame: 6 months
Assessed from 1 month onwards. Using SF36 (total score indicating a range of low to high Quality of life) and Minnessota questionaire (Minnesota Living With Heart Failure Questionnaire (MLHFQ) uses a scale from 0 to 105, where higher scores indicate poorer health-related quality of life)
Time frame: 6 months compared to baseline
Comparisson between groups of the percentage reduction in left ventricular end systolic volume at 6 months compared to baseline.
Time frame: 6 months
Comparison between groups in heart failure symptoms using The Minnesota Living with Heart Failure Questionnaire (health related quality of life- 0 to 105. Lower scores mean a better quality of life; higher scores mean worse limitations)
Barts & The London NHS Trust
Other
Acronym: CAMTAF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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